Dynamic compression devices and processes for making and using same

ABSTRACT

A compression device may include, but is not limited to, a threaded body, a sliding element, and a compression element connecting the threaded body and the sliding element. According to one embodiment, upon implantation, the threaded body contacts a first bony fragment and the sliding element contacts to a second bony fragment. In at least one embodiment, upon being engaged, the compression element applies sustained tension to the sliding element and opposing tension to the threaded body, thereby compressing the first bony fragment and the second bony fragment along a plane of contact promoting healing.

BACKGROUND

Injuries such as fractures may be treated, in part, using continuouscompression at the fracture. Compression typically involves compressingtwo or more bony fragments together to promote ossification and/orresettlement processes and heal the two or more bony fragments. Previousapproaches include a threaded compression device that is inserted intoand compresses together two or more bony fragments. In such approaches,compressive forces are typically generated by threaded elementsextending along at least a portion of the compression device (e.g., forexample, at either end of the device). However, these previousapproaches typically suffer compression performance issues, such asinsufficient or discontinuous compression. As one example, a surgeoninserts a threaded compression device into two bony fragments, therebygenerating a compressive force at a fracture site therebetween.Continuing the example, in response to the compressive force, the twobony fragments resettle and undergo resorption, thereby substantiallyreducing or fully dissipating the static compressive force. In thisexample, the inability of the threaded compression device to adapt tochanges at the insertion site and provide a dynamic compressive forcemay result in insufficient healing at the fracture site (e.g.,potentially requiring revision surgery, additional physical therapy,assistive devices, etc.).

Therefore, there is a long-felt but unresolved need for a dynamiccompression device that allows for dynamic generation of sustainedcompressive forces between bony fragments.

BRIEF SUMMARY OF THE DISCLOSURE

Briefly described, and according to one embodiment, aspects of thepresent disclosure generally relate to devices and assemblies fordynamic generation of sustained compression between bony structures, aswell as processes for making and using the same.

According to one embodiment, a compression device provides sustainedcompression to a target site by maintaining a predetermined level oftension between a first device portion affixed to a first bony fragmentand a second device portion affixed to a second bony fragment. Invarious embodiments, the compression device compresses the first bonyfragment and second bony fragment to stimulate bone resorption along oneor more planes of contact and, thereby, promote healing of the bonyfragments. In one or more embodiments, a compression device includes,but is not limited to, a threaded body, a sliding element, and acompression element connecting the threaded body and the slidingelement. According to one embodiment, upon implantation, the threadedbody is affixed to a first bony fragment and the sliding element isaffixed to a second bony fragment. In at least one embodiment, uponbeing engaged, the compression element applies sustained tension to thesliding element and opposing tension to the threaded body, therebycompressing the first bony fragment and the second bony fragment along aplane of contact. In one or more embodiments, in contrast to previoussolutions, the continuous tension of the sliding element generatessubstantially sustained compression at the plane of contact, which maybe sustained even with resorption and/or resettling of the first andsecond bony fragments.

In some embodiments, the compression element is stretched prior toinsertion of the compression device to a target site. For example, priorto insertion, the threaded body is pushed away from the sliding element,thereby stretching a compression element connected therebetween. In thisexample, to maintain the stretched state of the compression element, aninsertion tool connects to the sliding element and opposes movement ofthe threaded body toward the sliding element. Continuing with thisexample, the compression device is inserted into a target site and theinsertion tool is disconnected from the sliding element, therebyallowing for movement of the threaded body toward the sliding element inresponse to the contraction of the compression element from thestretched state.

In at least one embodiment, the compression element stretches duringinsertion of the compression device to a target site. In one example,the compression device rotates to penetrate into and secure to a targetsite. In this example, as the compression device rotates into the targetsite, the compression element stretches and, thereby, generates atensile load for applying compressive forces at the target site. In someembodiments, the compression element stretches following insertion ofthe compression device to a target site. In one example, followinginsertion of the compression device to a target site, a tool couples tothe compression device and reconfigures the compression element to adesired stretched state.

In various embodiments, the compression device includes one or morepenetrating features (e.g., self-tapping threads, etc.) that allow thecompression device to be rotated into a target site (e.g., bonymaterial). In one example, a threaded body and a sliding element eachinclude penetrating features that interface with and secure thecompression device into bone. In this example, a compression element isconnected, on opposing ends, to a first end of the threaded body and afirst end of the sliding element in a manner such that the compressionelement is stretched a particular distance and prevented fromcontracting, prior to insertion into a patient. In the same example, asecond end of the threaded body is inserted into a target site such thatthe sliding element is secured into a first bony fragment and thethreaded body is secured into a second bony fragment. Continuing theexample, the compression element is allowed to contract, therebyapplying opposing tensile forces to the sliding element and threadedbody. In the same example, the penetration features translate thetensile forces into a compressive force that compresses the first andsecond bony fragments toward each other.

In at least one embodiment, the threaded body and the sliding elementinclude one or more materials including, but not limited to, titanium,titanium alloys, and other suitable materials. According to oneembodiment, the threaded body includes a resilient material, such astitanium, which allows for walls of the threaded body to be thinner andlighter than would be achievable with previous device materials such asstainless steel, thereby advantageously reducing a material cost andweight of the compression device. In one or more embodiments, thecompression element includes a superelastic material, such as nitinol,that allows the compression element to be stretched a pre-determinedlength and the resultant tension to be used to provide continuous andsustained compression of bony fragments. In one or more embodiments, thecompression device is substantially formed of one or more superelasticmaterials. In one example, the compression device is substantiallyformed of nitinol material.

According to one embodiment, the threaded body and the sliding elementare cannulated such that they may receive and be internally connected toa compression element on either end thereof. In one or more embodiments,the compression element is cannulated to a predetermined diameter suchthat the compression device may be inserted along a guidewire (e.g., bythreading the guidewire through the cannulated regions of the slidingelement, compression device, and threaded body). In at least oneembodiment, the cannulation of the compression element is advantageousover previous approaches where the use of a centrally-disposed, butnon-cannulated compression element may prohibit the use of the centrallydisposed guidewire.

In some embodiments, the compression element is not cannulated. In oneexample, the compression element is non-cannulated and locatedoff-center from a central axis that runs the length of the threaded bodyand sliding element (e.g., that are cannulated to receive a guidewire).In another example, the compression element is non-cannulated and issubstantially centered on a central axis (e.g., and the compressiondevice receives a guidewire off-center from the central axis or aguidewire is not used).

In some embodiments, the cannulation of the compression element allowsfor pre-configuration of potential compression levels by providing aparticular degree of cannulation. In various embodiment, because thecannulation of the compression element and a maximum compressionprovided thereby may be inversely proportional, the level of potentialcompression responses of the compression element may be increased ordecreased based on decreasing or increasing a diameter of thecannulation. According to one embodiment, the cannulation allows for thecompression performance of the compression element to be configuredwithout changing a footprint of the compression element. In one or moreembodiments, variation of compression performance is achieved byselective laser modification (e.g., to remove material), braidedmaterial structures, and other techniques for adjusting a cross-sectionof the compression element. In at least one embodiment, the preservationof the compression element footprint allows for the preservation of thefootprints of other compression device elements (e.g., thickness of thethreaded body wall(s)) despite changing levels of compression.

In one example, a threaded body includes a particular cannulation thatallows for receipt of a compression element, but also maintains asufficient rigidity in the threaded body. In the same example, anincrease in the footprint of the compression element may require agreater cannulation of the threaded body that may compromise therigidity thereof. In an alternate example, an increase in thecannulation of the compression element may not cause an increase in thefootprint thereof and thus may not require a change in the threaded bodycannulation, thereby preserving the desired rigidity.

In various embodiments, the present technology allows for precise andaccurate configuration of varying compression levels without modifying afootprint of the compression device or compression element. In at leastone embodiment, the present compression devices and assemblies may bepre-stretched during a manufacturing or assembly process according todesired implementation parameters. In one example, a compression deviceis connected to an insertion tool and configured within a stretchingmechanism such that a sliding element is secured in place and thethreaded body can translate away from the stationary sliding element. Inthe same example, the stretching mechanism applies a force to thethreaded body such that the threaded body is translated away from thesliding element, thereby stretching the compression element and loadinga compressive force into the compression device. Continuing the example,a connection bolt is inserted through the insertion tool and securedinto the sliding element such that the compression element is preventedfrom retracting (e.g., thereby maintaining the loaded compressive forceuntil the connection bolt is removed).

In another example, stretching the compression element includes pullingthe connected threaded body and sliding element in opposite directionsto stretch the compression element and preventing retraction of thethreaded body and sliding element to preserve the stretched state. Inthis example, the retraction of the threaded body and sliding element istemporarily opposed via one or more mechanisms including, but notlimited to, pins, barriers, and releasable fittings (e.g., threadedconnections, luer locks, etc.) that prevent movement of the slidingelement relative to the threaded body, or vice versa. In anotherexample, prior to or during insertion of the compression device, thecompression element stretches to a predetermined level (e.g., via astretching mechanism or as a result of the insertion) and a barrierprevents the compression element from contracting toward a pre-stretchedstate. In this example, the barrier is removed or automatically degradesto allow the compression element to retract from the pre-stretched stateand, thereby, generate compressive forces.

In various embodiments, the compression device includes one or moremechanisms for precisely and accurately stretching the compressionelement, thereby providing a controlled pre-tensioning of thecompression element and, thus, an accurate configuration of a desiredcompression performance. In one or more embodiments, the one or moremechanisms include a connection bolt and an insertion tool. In one ormore embodiments, the insertion tool includes a plurality of pins thatare inserted through voids in the sliding element such that theplurality of pins contact an end of the threaded body (e.g., the slidingelement and threaded body being connected at either end of thecompression element). According to one embodiment, the insertion tool iscannulated such that the connection bolt may be received through andfreely rotate within the insertion tool. In at least one embodiment, alength of the connection bolt is greater than a length of the insertiontool such that, upon insertion, the connection bolt extends through afirst end of the insertion tool and a second end of the insertion tool.In one or more embodiments, the connection bolt and sliding elementinclude corresponding threads such that a secure, threaded connection isformed as the connection bolt is inserted through the insertion tool androtated into the sliding element.

In various embodiments, stretching the compression element includes, butis not limited to, inserting the insertion tool into the sliding elementsuch that the plurality of pins contact the threaded body, securing thecompression device and insertion tool into a stretching device such thatthe sliding element is prevented from moving, and applying a force tothe insertion tool that causes the plurality of pins to push thethreaded body away from the sliding element, thereby stretching thecompression element. According to one embodiment, following stretchingof the compression element, the connection bolt is inserted through theinsertion tool and securely connected to the sliding element such thatthe connection bolt opposes tensile forces generated by the compressionelement in response to stretching. In one or more embodiments, theconnection bolt preserves the stretched state of the compression elementas the compression device is inserted to a target site. In at least oneembodiment, following insertion of the compression device into two ormore bony fragments, the connection bolt is disconnected from thesliding element, thereby causing the compression element to applytensile forces to the sliding element and threaded body, and resultingin compression of the two or more bony fragments.

According to a first aspect, a compression device assembly including: A)an elongate threaded body including: 1) a threaded body first endincluding one or more threaded body threads for affixing the threadedbody to a first bony fragment of a patient and defining a hollowinterior of the threaded body; 2) a threaded body second end includingan opening to the hollow interior of the threaded body; B) a slidingelement for contacting a second bony fragment of the patient, defining ahollow interior, and including a sliding element first end including anelongated portion shaped to interface with the opening of the threadedbody second end; and C) a compression element operatively connected tothe threaded body and the sliding element, wherein: 1) the compressionelement includes nitinol; and 2) the compression device assembly isconfigured for applying compression to the first bony fragment and thesecond bony fragment via the compression element.

According to a second aspect, the compression device assembly of thefirst aspect or any other aspect, wherein: A) the compression element iscannulated; and B) the compression device is further configured forreceiving a guidewire through the cannulated compression element.

According to a third aspect, the compression device assembly of thesecond aspect or any other aspect, wherein: A) the compression elementis in a deformed state prior to insertion into the patient; and B)applying compression to the first bony fragment and the second bonyfragment via the compression element includes the compression elementreturning to a relaxed state from the deformed state.

According to a fourth aspect, the compression device assembly of thethird aspect or any other aspect, wherein the sliding element includes asliding element second end defining one or more pin openings forreceiving one or more pins of an insertion tool.

According to a fifth aspect, the compression device assembly of thefourth aspect or any other aspect, wherein the insertion tool includesone or more pins for being received by the one or more pin openings ofthe sliding element.

According to a sixth aspect, the compression device assembly of thefifth aspect or any other aspect, wherein the sliding element elongatedportion includes one or more pin slots for receiving the one or morepins of the insertion tool.

According to a seventh aspect, the compression device assembly of thesixth aspect or any other aspect, wherein a length of the one or morepin slots controls a maximum deformation distance of the compressiondevice assembly.

According to an eighth aspect, the compression device assembly of thesixth aspect or any other aspect, wherein the insertion tool defines ahollow interior.

According to a ninth aspect, the compression device assembly of theeighth aspect or any other aspect, wherein the insertion tool isconfigured to receive a connection bolt through the insertion toolhollow interior.

According to a tenth aspect, the compression device assembly of theninth aspect or any other aspect, wherein the sliding element includesone or more connection bolt threads for connecting the sliding elementto the connection bolt.

According to an eleventh aspect, the compression device assembly of thetenth aspect or any other aspect, wherein the connection bolt passesthrough the insertion tool hollow interior and attaches to the one ormore connection bolt threads of the sliding element for holding thesliding element in position with the compression element in the deformedstate.

According to a twelfth aspect, the compression device assembly of theeleventh aspect or any other aspect, wherein the connection boltincludes: A) a first end for connection to the sliding element; and B) asecond end, opposite the first end, that is configured to prevent a fulllength of the connection bolt passing through the insertion tool hollowinterior.

According to a thirteenth aspect, the compression device assembly of theeleventh aspect or any other aspect, wherein compression device assemblyis configured for receiving the guidewire through the hollow interior ofthreaded body, the cannulated compression element, and the hollowinterior of the sliding element, the hollow interior of the insertiontool, and through a hollow interior of the connection bolt for guidingthe compression device assembly to a particular location in the patient.

According to a fourteenth aspect, the compression device assembly of thethirteenth aspect or any other aspect, wherein, upon removing theconnection bolt, the compression device assembly applies compression tothe first bony fragment and the second bony fragment via the compressionelement returning to the relaxed state from the deformed state.

According to a fifteenth aspect, the compression device assembly of thefourteenth aspect or any other aspect, wherein the compression deviceassembly is configured such that the insertion tool is removable oncethe connection bolt is removed.

According to a sixteenth aspect, the compression device assembly of thefifteenth aspect or any other aspect, wherein the compression element isoperatively connected to the threaded body and the sliding element viathreads.

According to a seventeenth aspect, the compression device assembly ofthe sixteenth aspect or any other aspect, wherein a perimeter of theopening of the threaded body second end includes a hexagonal shape.

According to an eighteenth aspect, the compression device assembly ofthe sixteenth aspect or any other aspect, wherein: A) a set of threadsconnecting the sliding element and the compression element includes afirst thread direction; B) and a second set of threads connecting thethreaded body and the compression element includes a second threaddirection that is opposite the first thread direction.

According to a nineteenth aspect, a method including: A) inserting acompression device assembly into a patient, wherein the compressiondevice assembly includes: 1) an elongate threaded body including: i) athreaded body first end defining a hollow interior of the threaded body;and ii) a threaded body second end including an opening to the hollowinterior of the threaded body; 2) a sliding element defining a hollowinterior and including a sliding element first end including anelongated portion shaped to interface with the opening of the threadedbody second end; and 3) a nitinol compression element operativelyconnected to the threaded body and the sliding element; B) contactingthe threaded body with a first bony fragment of the patient via one ormore threaded body threads; C) contacting the sliding element with asecond bony fragment of the patient; and D) applying compression to thefirst bony fragment and the second bony fragment via the compressionelement returning to a relaxed state from a deformed state.

According to a twentieth aspect, the method of the nineteenth aspect orany other aspect, wherein: A) the compression element is cannulated; B)a guidewire is further received through the cannulated compressionelement; and C) the method further includes guiding the compressiondevice assembly along the guidewire to a particular location in thepatient;

According to a twenty-first aspect, the method of the nineteenth aspector any other aspect, wherein the compression element is in the deformedstate prior inserting the compression device assembly into the patient.

According to a twenty-second aspect, the method of the nineteenth aspector any other aspect, wherein the compression element is in the relaxedstate prior to inserting the compression device assembly into thepatient.

According to a twenty-third aspect, the method of the nineteenth aspector any other aspect, wherein: A) the compression element includes acompression element elongated portion between a compression elementfirst end and a compression element second end; and B) the compressionelement first end and the compression element second end each include asloped region for transitioning to the compression element elongatedportion.

According to a twenty-fourth aspect, the method of the nineteenth aspector any other aspect, wherein: A) the sliding element includes one ormore sliding element threads; and B) a diameter of the one or morethreaded body threads is less than a diameter of the one or more slidingelement threads.

According to a twenty-fifth aspect, the method of the nineteenth aspector any other aspect, wherein the threaded body includes a wall thicknessof about 0.5-4.0 mm.

According to a twenty-sixth aspect, a compression device assemblyincluding: A) an elongate threaded body including: 1) a threaded bodyfirst end including one or more threaded body threads for affixing thethreaded body to a first bony fragment of a patient and defining ahollow interior of the threaded body; and 2) a threaded body second endincluding a threaded body interface portion; B) a sliding element forcontacting a second bony fragment of the patient, defining a hollowinterior, and including a sliding element first end including a slidingelement interface portion shaped to interface with the threaded bodyinterface portion; and C) a compression element operatively connected tothe threaded body and the sliding element, wherein: 1) the compressionelement includes nitinol; and 2) the compression device assembly isconfigured for applying compression to the first bony fragment and thesecond bony fragment via the compression element.

According to a twenty-seventh aspect, the compression device assembly ofthe twenty-sixth aspect or any other aspect, wherein: A) the threadedbody interface portion includes a tapered portion; and B) the slidingelement interface portion includes an elongated portion for insertinginto the tapered portion.

According to a twenty-eighth aspect, the compression device assembly ofthe twenty-seventh aspect or any other aspect, wherein the taperedportion includes a perimeter with at least two corners.

According to a twenty-ninth aspect, the compression device assembly ofthe twenty-eighth aspect or any other aspect, wherein the taperedportion includes a hexagon-shaped perimeter.

According to a thirtieth aspect, the compression device assembly of thetwenty-sixth aspect or any other aspect, wherein: A) the threaded bodyinterface portion includes an elongated portion; and B) the slidingelement interface portion includes a tapered portion for receiving theelongated portion.

These and other aspects, features, and benefits of the claimedinvention(s) will become apparent from the following detailed writtendescription of the preferred embodiments and aspects taken inconjunction with the following drawings, although variations andmodifications thereto may be effected without departing from the spiritand scope of the novel concepts of the disclosure.

BRIEF DESCRIPTION OF THE FIGURES

The accompanying drawings illustrate one or more embodiments and/oraspects of the disclosure and, together with the written description,serve to explain the principles of the disclosure. Wherever possible,the same reference numbers are used throughout the drawings to refer tothe same or like elements of an embodiment, and wherein:

FIG. 1 shows a perspective view of an exemplary compression assemblyaccording to one embodiment of the present disclosure;

FIG. 2 shows an exploded view of an exemplary compression assemblyaccording to one embodiment of the present disclosure;

FIG. 3 shows a perspective view of an exemplary threaded body accordingto one embodiment of the present disclosure;

FIG. 4 shows a cross-sectional view of an exemplary threaded bodyaccording to one embodiment of the present disclosure;

FIG. 5 shows a perspective view of an exemplary compression elementaccording to one embodiment of the present disclosure;

FIG. 6 shows a cross-sectional view of an exemplary compression elementaccording to one embodiment of the present disclosure;

FIG. 7 shows a perspective view of an exemplary sliding elementaccording to one embodiment of the present disclosure;

FIG. 8 shows a top view of an exemplary sliding element according to oneembodiment of the present disclosure;

FIG. 9 shows a cross-sectional view of an exemplary sliding elementaccording to one embodiment of the present disclosure;

FIG. 10 shows a cross-sectional view of an exemplary insertion toolaccording to one embodiment of the present disclosure;

FIG. 11 shows a cross-sectional view of an exemplary connection boltaccording to one embodiment of the present disclosure;

FIG. 12 shows a front view of an exemplary compression assemblyaccording to one embodiment of the present disclosure;

FIG. 13 shows a bottom view of an exemplary compression device accordingto one embodiment of the present disclosure;

FIG. 14 shows a top view of an exemplary insertion tool and connectionbolt according to one embodiment of the present disclosure;

FIG. 15 shows a back view of an exemplary compression assembly accordingto one embodiment of the present disclosure;

FIG. 16 shows a left-side view of an exemplary compression assemblyaccording to one embodiment of the present disclosure;

FIG. 17 shows a right-side view of an exemplary compression assemblyaccording to one embodiment of the present disclosure; and

FIG. 18 shows an exemplary compression process, according to oneembodiment of the present disclosure.

DETAILED DESCRIPTION

For the purpose of promoting an understanding of the principles of thepresent disclosure, reference will now be made to the embodimentsillustrated in the drawings and specific language will be used todescribe the same. It will, nevertheless, be understood that nolimitation of the scope of the disclosure is thereby intended; anyalterations and further modifications of the described or illustratedembodiments, and any further applications of the principles of thedisclosure as illustrated therein are contemplated as would normallyoccur to one skilled in the art to which the disclosure relates. Alllimitations of scope should be determined in accordance with and asexpressed in the claims.

Whether a term is capitalized is not considered definitive or limitingof the meaning of a term. As used in this document, a capitalized termshall have the same meaning as an uncapitalized term, unless the contextof the usage specifically indicates that a more restrictive meaning forthe capitalized term is intended. However, the capitalization or lackthereof within the remainder of this document is not intended to benecessarily limiting unless the context clearly indicates that suchlimitation is intended.

Overview

Aspects of the present disclosure generally relate to devices andassemblies for providing precise and accurate compression of bonystructures, as well as processes for making and using the same.

In one or more embodiments, a compression device includes, but is notlimited to, a threaded body, a sliding element, and one or morecompression elements. In at least one embodiment, the threaded body iscannulated such that a portion (or, in some embodiments, a substantiallength) of the compression element is sheathed by the threaded body. Inone or more embodiments, the threaded body and the sliding elementinclude internal fittings for connecting to corresponding fittings oneach end of a compression element. In one example, the threaded body andthe sliding element each include threads sized to receive correspondingthreads of the compression element.

In at least one embodiment, the compression element provides for dynamicgeneration of sustained compressive forces between two or more bonyfragments (e.g., along a plane of fracture through which the compressiondevice is inserted). According to one embodiment, the compressionelement is cannulated according to a predetermined diameter. In at leastone embodiment, the cannulation of the compression element, threadedbody, and sliding element permit the compression device to be insertedalong a guide wire (e.g., translated through the cannulated portions)into a target site. In at least one embodiment, the cannulation of thecompression element allows for pre-configuration of varying compressionlevels without affecting an overall footprint of the compressionelement.

In various embodiments, the compression element includes a superelasticmaterial, such as nitinol. In one or more embodiments, the threadedbody, sliding element, insertion tool, connection rod, and/or connectingpins include one or more materials including, but not limited to,titanium, titanium alloys, and other materials.

EXEMPLARY EMBODIMENTS

Referring now to the figures, for the purposes of example andexplanation of the fundamental processes and components of the disclosedsystems and methods, reference is made to FIG. 1, which shows aperspective view of an exemplary compression assembly 100 according tovarious embodiments of the present disclosure. As will be understood andappreciated, the exemplary compression assembly 100 shown in FIG. 1represents merely one approach or embodiment of the present system, andother aspects are used according to various embodiments of the presentsystem.

In various embodiments, the assembly 100 includes a compression device101 and an insertion tool 102. In some embodiments, the compressiondevice 101 and insertion tool 102 are provided separately (e.g.,unattached or un-assembled), such as, for example, in a kit. Accordingto one embodiment, the compression device 101 and insertion tool 102 areprovided as shown in FIG. 1 and the compression device 101 is providedpre-stretched according to predetermined parameters. In alternateembodiments, the compression device 101 and insertion tool 102 areprovided as the assembly 100, but the compression device is notpre-stretched (e.g., the pre-stretching being performed by a user, suchas a technician or surgeon). In some embodiments, the compression device101 is insertable without the insertion tool 102.

In one or more embodiments, the compression device 101 includes athreaded body 103, a sliding element 106, and a compressive element 201(not shown in FIG. 1, see FIG. 2). In at least one embodiment, thethreaded body 103 and the sliding element 106 are configured topenetrate into biological material, such as bone, at a target site. Invarious embodiments, the threaded body 103 and sliding element 106 arecannulated such that they may receive the compressive element 201 and/ora guidewire (e.g., a K-wire) through the cannulated portions.

According to one embodiment, the threaded body 103 includes a first end104 and a second end 105. In various embodiments, the threaded body 103includes a tip 109 at the first end 104. In one or more embodiments, thethreaded body 103 includes a shaft 114 between the second end 105 and atip end 116 (e.g., end of the tip 109). In one or more embodiments, thetip 109 is integrally formed with the shaft 114. According to oneembodiment, the shaft 114 and the tip 109 are connected by one or moremechanisms including, but not limited to, threaded fittings, adhesives,welds, friction fits, and other connection mechanisms.

In at least one embodiment, the tip 109 is configured to penetrate anddrill into tissue, such as bone, at a target site. In one or moreembodiments, the tip 109 includes threads 110 and one or more blades 111for drilling into material, such as bone, via rotation of thecompression device 101. In various embodiments, the threads 110interface with tissue, such as bone, to secure an implanted position ofthe compression device 101 and resist pullout and pull-through forcesexperienced thereby.

In at least one embodiment, the threaded body 103 and sliding element106 are attached to either end of the compression element 201. In oneexample, the threaded body 103 and sliding element 106 include innerthreads configured to interface with corresponding threads of thecompression element 201 (as discussed regarding FIG. 2).

As will be understood from discussions herein, the threaded body 103 andthe sliding element 106 may interface in any suitable way. According toone embodiment, at the second end 105 of the threaded body 103 isconfigured to receive a portion of the sliding element 106. In at leastone embodiment, the second end 105 includes an opening that receives anend of the sliding element 106 (as shown in FIG. 3). According to oneembodiment, the angular interface between the sliding element 106 andthe second end 105 allows the sliding element 106 and threaded body 103to be rotated in unison, for example, during insertion or extraction ofthe compression device 101.

According to one or more embodiments, the sliding element 106 mayreceive a portion of the threaded body 103. In these embodiments (andothers), the threaded body 103 includes an elongated portion (not shown)that is received by the sliding element 106, such that the interfacebetween the sliding element 106 and threaded body 103 allows the slidingelement 106 and the threaded body 103 rotate in unison.

In one or more embodiments, the sliding element 106 is configured toreceive a plurality of control pins 108 that extend from the insertiontool 102. In at least one embodiment, the plurality of control pins 108are integrally formed with the insertion tool 102. In some embodiments,the plurality of pins 108 are inserted and/or attached to the insertiontool 102. In one or more embodiments, the sliding element 106 includesthreads 107 for drilling into tissue, such as bone, and for securing animplanted position of the compression device 101. In variousembodiments, the threads 107 resist pullout and pull-through forcesexperienced by the compression device 101. In at least one embodiment,the sliding element 106 includes one or more self-tapping features 112that pierce tissue and expand an implantation site to accommodate thesliding element 106. In one embodiment, the one or more self-tappingfeatures 112 are flutes with sharpened edges that cut threads intotissue as the compression device 101 is rotated, the formed threadsbeing sized to interface with the threads 107 and secure the compressiondevice 101.

In one or more embodiments, the compression device 101 is insertedthrough a target such that the sliding element 106 contacted or affixedto a first bony fragment and the threaded body 103 is contacted oraffixed to a second bony fragment (e.g., threads 110 and threads 107securing the position of the compression device 101). According to oneembodiment, following implantation, the compression element 201 isengaged and applies a tensional force to the sliding element 106 and anopposing tensional force to the threaded body 103. In variousembodiments, the opposing tensional forces compress the sliding element106 and the threaded body 103 toward each other and, thereby, causes thethreads 110 and threads 107 to compress the first bony fragment and thesecond bony fragment. In alternate embodiments, the sliding element 106and/or threaded body 103 includes a shaped head including a surfaceoriented and extending perpendicular to the length of the compressiondevice 101 such that the surface interfaces with or otherwise contactssurrounding tissue, thereby generating the compressive force.

In at least one embodiment, the threaded body 103 includes a generallycylindrical shape. In various embodiments, the threaded body 103 (e.g.,or at least the shaft 114) tapers in diameter between the second end 105and the tip end 116. In one or more embodiments, the threaded body 103includes a substantially smooth surface 113 that allows the compressiondevice 101 to translate through a target site and into biologicalmaterials, such as bone.

In one or more embodiments, the threaded body 103 and the slidingelement 106 include one or more materials including, but not limited to,titanium, titanium alloys, and other materials. In some embodiments, thethreaded body 103 and sliding element 106 include different materials.In one or more embodiments, the one or more materials included in thevarious elements of the compression device 101 are biocompatible andbiologically inert.

In various embodiments, a section line 228A, 228B indicates a crosssection 1000 and a cross-section 1100 that are shown in FIG. 10 and FIG.11, respectively.

FIG. 2 shows an exploded view of the assembly 100. In variousembodiments, the assembly 100 includes the compression device 101,insertion tool 102, and a connection bolt 211. According to oneembodiment, the compression device 101 includes the threaded body 103configured for attachment to a first end 203 of the compression element201, and includes the sliding element configured for attachment to asecond end 205 of the compression element 201.

In various embodiments, the compression element 201 includes a generallycylindrical shape. In at least one embodiment, a cross-section of thecompression element 201 includes one or more shapes, including, but notlimited to, circles, ellipses, semi-circles (or other partial circles),discs, other polygons, and other shapes. According to one embodiment,the compression element 201 includes a shaft 202 that is cannulated to apredetermined diameter. In at least one embodiment, the shaft 202includes a slot 206. In one or more embodiments, the slot 206 is formedfrom cannulation of the compression element 201. In various embodiments,in the assembled compression device 101, the slot 206 is open to theinternal portion of the threaded body 103. In alternative embodiments,the slot 206 is absent. For example, the shaft 202 is cannulated and isfully enclosed by an exterior surface.

According to one embodiment, the first end 203 and second end 205 of thecompressive element 201 includes threads 204A, 204B for interfacing withcorresponding threads of the threaded body 103 and the sliding element106. In at least one embodiment, the threads 204B and threads 204Ademonstrate opposing handedness. In one example, the threads 204B areleft-handed threads, and the threads 204A are right-handed threads. Inone or more embodiments, the opposing handedness of the threads 204A andthreads 204B allows for the compression element 201 to be connected tothe threaded body 103 while remaining connected to the sliding element106.

In various embodiments, the sliding element 106 includes a first portion207 and a second portion 209. In one or more embodiments, the secondportion 209 is shaped to fit into a receiving portion of the threadedbody 103 towards at the second end 105 thereof. In at least oneembodiment, the second portion 209 includes one or more shapesincluding, but not limited to, circles, hexalobes, hexagons, triangles,squares, and other polygons. According to one embodiment, the shape ofthe second portion 209 conforms to a shape of the receiving portion ofthe threaded body 103. In one or more embodiments, the second portion209 includes a void 208 for receiving the second end 205 of thecompression element. In various embodiments, the void 208 includes aninternal portion 210 that is threaded to interface with the threads 204Aand thereby secure the sliding element to the compression element 201.In alternate embodiments, the internal portion 210 includes one or morenon-threaded connection mechanisms, such as, for example, a bayonetfitting.

In one or more embodiments, the connection bolt 211 is configured formaintaining the compression element 201 in a deformed state. Accordingto one embodiment, the connection bolt 211 includes a substantiallycylindrical shape. In at least one embodiment, a cross-section of therod 211 includes one or more shapes including, but not limited to,circles, semi-circles, hexagons, and other polygons. In one or moreembodiments, the connection bolt 211 includes a head 223 at a first end218 and a connection mechanism 221 at a second end 220.

In at least one embodiment, the connection bolt 211 is inserted into thecompression assembly 100 during an assembly process. In one or moreembodiments, the pre-tensioning of the compression element 201 isperformed according to predetermined implantation parameters, forexample, a desired compression force to be applied to bony fragments ofa patient. In at least one embodiment, the compression element 201 isinserted into the second portion 209 of the sliding element 106 androtated to secure the connection via the interface of threads 204A andthreads 208. In one or more embodiments, the compression element 201 andsecond portion 209 of the sliding element 106 are inserted into thesecond end 105 of the threaded body 103. In various embodiments, at thesecond end 105 an opening (shown as opening 301 in FIG. 3) receives thesecond portion 209 of the sliding element 106. According to oneembodiment, the compression element 201 and threaded body 103 areconnected by twisting the compression element 201 (e.g., via a toolinserted through the first end 104) and thereby causing the threads 204Band internal threads 415 (see FIG. 4) to engage and secure theconnection.

In one or more embodiments, the insertion tool 102 is connected to thecompression device 101 via the plurality of control pins 108 insertedinto a first end 215 of the insertion tool 102 and further insertedthrough the voids 707 (see FIG. 7) of the sliding element 106. Invarious embodiments, stretching the compression element 201 includessecuring a position of the sliding element 106 while applying a force tothe threaded body 103 via the plurality of control pins 108. In at leastone embodiment, the applied force causes the threaded body 103 totranslate away from the stationary sliding element 106, thereby causingthe compression element 201 to stretch. According to one embodiment, tosecure the stretched/deformed state of the compression element 201, aconnection bolt 211 is inserted through a second end 217 of theinsertion tool 102 and further inserted into the sliding element 106. Inat least one embodiment, the head 223 (which may be in the form of anail or screw head) prevents further insertion of the connection bolt211 into the compression assembly 100. In various embodiments, theconnection bolt 211 is rotated to connect to the sliding element 106 byan interface of the threads 221 and internal threads 908 (see FIG. 9).According to one embodiment, upon being connected to the sliding element106, the connection bolt 211 prevents the sliding element 106 fromtranslating toward the threaded body, thereby preserving thestretched/deformed state of the compression element 201.

According to one embodiment, the connection bolt 211 is provided in akit (e.g., including the components of the compression assembly 100) anda user inserts and rotates the connection bolt 211 to achieve a desiredpre-tensioning of the compression device 101.

In one or more embodiments, a maximum stretch of the compression element201 may be configured based on one or more factors including, but notlimited to, the length of the threads 221, the length of the controlpins 108, and/or the length of the insertion tool 102. In at least oneembodiment, the one or more factors prevent the compression element 201being stretched to or past a failure length (e.g., a stretch distance atwhich the compression element breaks or is otherwise rendereddysfunctional). In one example, a length of the control pins 108 is suchthat a maximum stretch length of the compression element 201 is lessthan a failure stretch length of the material thereof. In anotherexample, a kit including the compression assembly 100 includes multiplesets of control pins 108, each set having control pins 108 of aparticular length, thereby providing a user with various options for themagnitude of compression provided by the compression device 101.

In at least one embodiment, the control pins 108 include a sequence ofvisible markings that are revealed as the sliding element 106 isprogressively drawn upwards during pre-stretching. In one or moreembodiments, as revealed, each visible marking indicates the magnitudeof compression being provided by the current stretch length of thecompressive element 201. In one example, the sequence of visiblemarkings include compression magnitudes. In another example, thesequence of visible markings include stretch length magnitudescorresponding to the stretch length of the compression element 201. Inanother example, the sequence of visible markings includes a failurepoint marker, such as a red line, that indicates a maximum stretchlength of the compression element 201 before failure or otherdysfunction may occur.

FIG. 3 shows a perspective view of the threaded body 103. In one or moreembodiments, the threaded body 103 includes one or more materialsincluding, but not limited to, titanium, stainless steel, and othermaterials. In at least one embodiment, the threaded body 103 includestitanium that allows the threaded body 103 to demonstrate desiredrigidity while maintaining a sufficiently small footprint.

According to one embodiment, the threaded body 103 includes an opening301 shaped to receive the second portion 209 of the sliding element 106(see FIG. 2). In at least one embodiment, the opening 301 is shaped toconform to a footprint of the second portion 209 of the sliding element106. In one example, the second portion 209 of the sliding element 106includes a hexagonal footprint and the opening 301 includes a hexagonalshape sized to conform to the hexagonal footprint. In variousembodiments, the shape of the opening 301 includes, but is not limitedto, hexalobe, circle, square, hexagon, and other polygons. In one ormore embodiments, a sloped region 303 transitions the second end 105 tothe opening 301. It will be understood and appreciated that one or moreslopes of varying degree and/or arrangement may transition the secondend 105 to the opening 301. In some embodiments, the second end 105transitions to the opening 301 without a slope. In various embodiments,a section line 305A, 305B indicates a cross-section 400 of the threadedbody 103 that is shown in FIG. 4.

FIG. 4 shows a cross-section 400 of the threaded body 103. In one ormore embodiments, the threaded body 103 includes a length 404 betweenthe second end 105 and first end 104. According to one embodiment, thelength 404 measures about 20-160 mm, about 20-40 mm, about 40-60 mm,about 60-80 mm, about 80-100 mm, about 100-120 mm, about 120-140 mm, orabout 140-160 mm. In one or more embodiments, the shaft 114 includes alength 406 between the second end 105 and the tip end 116. In at leastone embodiment, the length 406 measures about 40-80 mm, about 40-50 mm,about 50-60 mm, about 60-70 mm, about 67 mm, or about 70-80 mm.

In one or more embodiments, the threaded body 103 is cannulated betweenthe first end 104 and the second end 105. According to one embodiment,between the first end 105 and an end 402, the threaded body 103 includesa diameter 403 that measures about 1.0-4.0 mm, about 1.0-1.5 mm, about1.5-2.0 mm, about 2.0-2.5 mm, about 2.6 mm, about 2.5-3.0 mm, about3.0-3.5 mm, or about 3.5-4.0 mm. In at least one embodiment, thediameter 403 provides sufficient rigidity in the threaded body 103 andpermits passage of the compression element 201 through the threaded body103.

In one or more embodiments, the opening 301 includes a length 405between the second end 105 and the end 402. In at least one embodiment,the length 405 measures about 5-15 mm, about 5-7 mm, about 7-9 mm, about9-11 mm, about 10 mm, about 11-13 mm, or about 13-15 mm. In variousembodiments, the opening 301 includes a width 407. According to oneembodiment, the width 407 measures about 3.0-6.0 mm, about 3.0-4.0 mm,about 4.0-5.0 mm, about 4.68 mm, or about 5.0-6.0 mm. In at least oneembodiment, the width 407 is based on a footprint of the second portion209 of the sliding element 106 (e.g., as shown in FIG. 2).

In one or more embodiments, the shaft 114 includes a diameter 408 thatmeasures about 4.0-8.0 mm, about 4.0-5.0 mm, about 5.0-6.0 mm, about6.0-7.0 mm, about 6.15 mm, or about 7.0-8.0 mm. In various embodiments,the shaft 114 tapers from the diameter 408 at the second end 105 to asecond diameter 409 toward the first end 104. According to oneembodiment, the second diameter 409 measures about 3.0-6.0 mm, about3.0-4.0 mm, about 4.0-5.0 mm, about 4.75 mm, or about 5.0-6.0 mm. Insome embodiments, the diameter of the shaft 114 is substantiallyconstant (e.g., equal to a substantially constant diameter 408 ordiameter 409).

In one or more embodiments, the tip 109 includes a length 411 betweenthe tip end 116 and the first end 104. According to one embodiment, thelength 411 measures about 17.0-22.0 mm, about 17.0-18.0 mm, about18.0-19.0 mm, about 19.0-20.0 mm, about 19.271 mm, about 20.0-21.0 mm,or about 21.0-22.0 mm. In various embodiments, the tip 109 includes adiameter 413 that measures about 5.0-9.0 mm, about 5.0-6.0 mm, about6.0-7.0 mm, about 7.0 mm, about 7.0-8.0 mm, or about 8.0-9.0 mm. In atleast one embodiment, the diameter 413 is based on a height of thethreads 110 as measured, for example, from the surface 113 of the shaft114. In one or more embodiments, the diameter 413 is based on a desiredbore size for inserting the compression device 101 into a target site.

In various embodiments, the threaded body 103 includes an internalportion 415 that includes one or more connection mechanisms forconnecting a compression element 201 to the threaded body 103. In atleast one embodiment, the internal portion 415 includes threading 416configured to interface with threads 204B (FIG. 2) and secure acompression element 201 to the threaded body 103. In alternateembodiments, the internal portion includes one or more connectionmechanisms, such as, for example, a bayonet fitting or other suitablemechanisms. According to one embodiment, the internal portion 415includes a length 417 that measures about 5.0-15.0 mm, about 5.0-7.0 mm,about 7.0-9.0 mm, about 9.0-11.0 mm, about 10.0 mm, about 11.0-13.0 mm,or about 13.0 mm-15.0 mm.

In various embodiments, the threaded body 103 includes a wall thickness419. As will be understood from discussions herein, the wall thickness419 may vary along a length of the threaded body 103. In one or moreembodiments, the wall thickness 419 measures about 0.5-4.0 mm, about0.5-1.0 mm, about 1.0-1.5 mm, about 1.25 mm, about 1.5-2.0 mm, about2.15 mm, about 2.0-2.5 mm, about 2.5-3.0 mm, about 3.0-3.5 mm, about3.5-4.0 mm, or about 4.0-4.5 mm. In at least one embodiment, the wallthickness 419 maintains sufficient levels of rigidity in the threadedbody 103 and permits passage of the compression element 201 through thethreaded body 103. According to one embodiment, the wall thickness 419varies between about 0.5-2.0 mm between the first end 104 and the secondend 105. In one example, the wall thickness 419 measures about 0.5 mm atthe second end 105 and about 1.25 mm at the end 402. In at least oneembodiment, the threaded body 103 may include an average wall thicknessof about 1.25 mm.

FIG. 5 shows a perspective view of the compression element 201. In oneor more embodiments, the shaft 202 and slot 206 thereof are locatedbetween a first end 501A and a second end 501B. In one or moreembodiments, the slot 206 includes a width 502 that measures about1.0-3.0 mm, about 1.0-1.5 mm, about 1.5-2.0 mm, about 1.88 mm, about2.0-2.5 mm, or about 2.5-3.0 mm. In at least one embodiment, the width502 provides a particular level of cannulation in the shaft 202, suchas, for example, a cannulation level sufficient for passing a guidewirethrough the shaft 202.

In at least one embodiment, a shape of the shaft 202 includes agenerally flat top surface 505A, 505B spaced opposite from a generallyflat or rounded bottom surface (not shown). In one or more embodiments,a first convex surface 506 and an oppositely-oriented second convexsurface (not shown) connect to and bridge corresponding edges of the topsurface 505A, 505B and bottom surface. In at least one embodiment, across-section of the shaft 202 (e.g., taken perpendicular to the sectionline 508A, 508B) includes two generally trapezoidal shapes in which alongest side of each shape includes a convex curve.

In one or more embodiments, at each end 501A, 501B, the shaft 202includes sloped portions 507A, 507B that transition the shaft 202 to thesecond end 205 and first end 203, respectively. In at least oneembodiment, the sloped portions advantageously reduce stressconcentrations as compared to other connections or transitions, such ascorners.

In various embodiments, the compression element 201 forms a notch 209near the first end 203 that is shaped to receive a tool for connectingthe compression element 201 to the threaded body 103. In one example,the notch 509 includes a predetermined depth that allows the notch 509to receive and engage with a tool for rotating the compression element201. In one example, the notch 509 is configured to receive a flatheadscrew driver inserted through a first end 104 (see. FIG. 1) of thethreaded body 103 for rotating the compression element 201 within thethreaded body 103 and engaging threaded connections therebetween.

In one or more embodiments, the compression element 201 is cannulated toa predetermined diameter. In at least one embodiment, the cannulation ofthe compression element 201 allows for the insertion of the compressionelement 201 along a guidewire, such as a K-wire, received through thecannulation. In various embodiments, the cannulation diameter maydetermine a maximum compressive force provided by the compressionelement 201. According to one embodiment, the degree of cannulation ofthe compression element 201 provides a predetermined compression levelin the compression device 101. In at least one embodiment, thecannulation of the compression element 201 advantageously allows forprogrammable compression levels without changing a footprint of thecompression element (or device overall). For example, withoutcannulation, providing a first level of compression may require acompression element of a first diameter, while providing a second levelof compression may require a compression element of a second diameter.In the same example, the second diameter is greater than the firstdiameter and, thus, increases a footprint of the compression element.Continuing the example, the increased footprint of the compressionelement may further require an increase in the footprint of the threadedbody 103 or an increase in the cannulation thereof, which may compromisethe rigidity of the threaded body 103 and undesirably increase a risk ofundesirable bending, or other deformations and failures.

According to one embodiment, a section line 508A, 508B indicates across-section 600 of the compression element 201 shown in FIG. 6.

FIG. 6 shows a cross-section 600 of the compression element 201. Invarious embodiments, the compression element 201 generates compressiveloads (e.g., via application of tensile forces) that measure about50-800 Newtons (N), about 50-100 N, about 100-150 N, about 150-200 N,about 200-250 N, about 250-300 N, about 300-350 N, about 350-400 N,about 400-450 N, about 450-500 N, about 500-550 N, about 550-600 N,about 600-650 N, about 650-700 N, about 700-750 N, about 750-800 N, orabout 800-850 N. According to one embodiment, the compression element201 includes a length 601 between the second end 205 and first end 203.In various embodiments, the length 601 measures about 20-140 mm, about20-40 mm, about 30 mm, about 40-60 mm, about 60-80 mm, about 80-100 mm,about 100-120 mm, about 120 mm, or about 120-140 mm. In at least oneembodiment, the second end 205 and first end 203 include a diameter 603that measures about 1.0-4.0 mm, about 1.0-1.5 mm, about 1.5-2.0 mm,about 2.0-2.5 mm, about 2.5 mm, about 2.5-3.0 mm, about 3.0-3.5 mm, orabout 3.5-4.0 mm. According to one embodiment, the diameter 603 is atleast partially determined by a size of the threads 204A, 204B. In atleast one embodiment, the threads 204A, 204B are M2.5×0.45 threads.

In one or more embodiments, the shaft 202 includes a thickness 605between opposing edges 606 and 607. According to one embodiment, thethickness 1105 measures about 0.5-3.0 mm, about 0.5-1.0 mm, about 0.9mm, about 1.0-1.5 mm, about 1.5-2.0 mm, about 2.0-2.5 mm, or about2.5-3.0 mm. In at least one embodiment, the compression element 201includes an internal diameter 609 that measures about 0.25-2.0 mm, about0.25-0.5 mm, about 0.5-0.75 mm, about 0.75-1.0 mm, about 1.0-1.25 mm,about 1.1 mm, about 1.25-1.5 mm, about 1.5-1.75 mm, or about 1.75-2.0mm. In various embodiments, the internal diameter 609 refers to thelevel of cannulation of the compression element 201. According to oneembodiment, the internal diameter 609 is such that a guidewire may beinserted through the compression element 201.

FIG. 7 shows a perspective view of a sliding element 106. In variousembodiments, the sliding element 106 achieves various functionsincluding, but not limited to, temporarily tethering the rotation of aninsertion tool and a compression device (e.g., thereby facilitatinginsertion of the compression device to a target site), enabling aconnected threaded body to be pushed away from the sliding element 106such that a compression element connected therebetween is stretched, andopposing movement of the threaded body toward the sliding element 106(e.g., thereby maintaining the stretched state of a compressionelement).

In one or more embodiments, the sliding element 106 includes a firstportion 207 toward a first end 701 and a second portion 209 toward asecond end 703. In some embodiments, when the compression device 101 isinserted to a target site, the first portion 207 abuts against bone atthe target site, thereby applying a compressive force. In variousembodiments, the first portion 207 includes a substantially roundedshape, such as, for example, a substantially smooth lag shape (e.g.,without threads) that contacts and applies compression to a target siteas the compression device 101 is inserted by pressing against an end ofa bone, opposed to being drilled into bone via threads (e.g., andfurther applies compression in response to tensile forces from aconnected compression element).

In at least one embodiment, the first portion 207 includes threads 107for penetrating tissue and securing an implanted position of thecompression device 101. In some embodiments, near the first end 701, thefirst portion 207 includes a substantially rounded and threadless firstregion followed by a second region that includes threads 107.

In various embodiments, at the first end 701, the first portion 207forms a void 705 configured for receiving the connection bolt 211 and/ora guidewire. According to one embodiment, the void 705 includes one ormore shapes including, but not limited to, hexalobe, circle, square,hexagon, and other polygons. In at least one embodiment, the void 705 isshaped to conform to a footprint of the first end 215 (FIG. 2) of aninsertion tool. In some embodiments, the first portion 207 includes oneor more flutes 704 that allow the sliding element 106 to self-tap into atarget site (e.g., in response to rotation).

In various embodiments, the first portion 207 includes a plurality ofvoids 707A, 707B, 707C, 707D, 707E, 707F, each configured for receivinga control pin 108 and extending through the first portion 207. In atleast one embodiment, the second portion 209 includes a plurality ofchannels 708A, 708B, 708C, each configured for receiving a control pin108 inserted through a void 707. According to one embodiment, a length710 of the channels 708A, 708B, 708C may determine a maximum stretchdistance of the compression element 201. For example, an increasedlength 710 may reduce the maximum stretch distance of the compressionelement 201. In various embodiments, the length 710 measures about3.0-9.0 mm, about 3.0-4.0 mm, about 4.0-5.0 mm, about 5.0-6.0 mm, about6.0-7.0 mm, about 6.18 mm, about 7.0-8.0 mm, or about 8.0-9.0 mm.

In one or more embodiments, upon insertion into the plurality of voids707A-F, the plurality of control pins 108 allow the compression device101 (FIG. 1) to be rotated via rotation of the insertion tool 102. In atleast one embodiment, the plurality of control pins 108 and voids 707A-Fallow for the threaded body 103 to be pushed away from the slidingelement 106 via a force applied to the insertion tool 102 (e.g., whenthe sliding element 106 is secured against movement for the purposes ofstretching the compression element 201 of the compression device 101).In one or more embodiments, when the compression element 201 isstretched and a connection bolt 211 is inserted into the insertiondevice 102, the plurality of control pins 108 maintain a stretched stateof the compression element 201 by preventing movement of the threadedbody 103 toward the sliding element 106.

In some embodiments, the control pins 108 are omitted and the second end217 (FIG. 2) conforms to the shape of the opening 705. In one example,the opening 705 receives the second end 217 of the insertion tool 102 toallow for rotation of the compression device 101 via rotation of theinsertion tool 102. In the same example, stretching the compressionelement 201 of the assembled compression device 101 includes securingthe threaded body 103 against movement and applying a force to thesliding element 106 such that the sliding element 106 moves away fromthe threaded body 103, thereby stretching the compression element 201.In an example, stretching the compression element 201 includes securingthe sliding element 106 in a stationary position and applying a force tothreaded body 103 that causes the threaded body 103 to move away fromthe sliding element 106, thereby stretching the compression element 201.

In one or more embodiments, the stretched state of the compressionelement 201 can be maintained by providing a barrier, such as a sectionof material, between the sliding element 106 and threaded body 103 thatprevents movement of the threaded body 103 toward the sliding element106. In one example, a removable section of material is inserted betweenthe sliding element 106 and threaded body 103 following stretching. Inthis example, during or after insertion of the compression device 101 toa target site, the section of material is removed, thereby allowingmovement between the threaded body 103 and sliding element 106.

According to one embodiment, a section line 709A, 709B indicates across-section 900 of the sliding element 106 shown in FIG. 9.

FIG. 8 shows a top view of a sliding element 106. In one or moreembodiments, the plurality of voids 707A, 707B, 707C, 707D, 707E, 707Feach include a diameter 801 that measures about 0.5-3.0 mm, about0.5-1.0 mm, about 1.0-1.5 mm, about 1.1 mm, about 1.5-2.0 mm, about2.0-2.5 mm, or about 2.5-3.0 mm. In at least one embodiment, each void707 is located a distance 803 from a central point 802 of the slidingelement 106 (e.g., as measured from a nearest point of the void 707 tothe central point 802). According to one embodiment, the distance 803measures about 2.0-8.0 mm, about 2.0-3.0 mm, about 3.0-4.0 mm, about 3.6mm, about 4.0-5.0 mm, about 5.0-6.0 mm, about 5.8 mm, about 6.0-7.0,about 6.5 mm, or about 7.0-8.0.

FIG. 9 shows a cross-section 900 of a sliding element 106. In one ormore embodiments, the sliding element 106 includes a total length 901between a first end 701 and second end 703. In at least one embodiment,the total length 901 measures about 10.0-40.0 mm, about 10.0-15.0 mm,about 15.0-20.0 mm, about 19.0 mm, about 20.0-25.0 mm, about 25.0-30.0mm, about 30.0-35.0, or about 35.0-40.0. In one or more embodiments, thefirst portion 207 includes a length 903 between the first end 701 and acentral region 902. According to one embodiment, the length 903 measuresabout 6.0-12.0 mm, about 6.0-7.0 mm, about 7.0-8.0 mm, about 8.0-9.0 mm,about 9.0 mm, about 9.0-10.0 mm, about 10.0-11.0 mm, or about 11.0-12.0mm. In various embodiments, the internal portion 210 includes a length905 between a region 904 and the second end 703. In one or moreembodiments, the length 905 measures about 4.0-9.0 mm, about 4.0-5.0 mm,about 5.0-6.0 mm, about 6.0-7.0 mm, about 6.63 mm, about 7.0-8.0 mm, orabout 8.0-9.0.

According to one embodiment, the sliding element 106 includes a firstthreaded portion 907 that is configured to interface with a connectionmechanism 221 and thereby secure the sliding element 106 to a connectionbolt 211. In one or more embodiments, the threaded portion 907 includesthreading 908 to interface with the threads of the connection mechanism221. In alternate embodiments, the threaded portion 907 includes one ormore non-threaded connection mechanisms, such as, for example, a bayonetfitting. In at least one embodiment, the threaded portion 907 includes alength 911 between a first section 909 and a second section 910.According to one embodiment, the length 911 measures about 2.0-8.0 mm,about 2.0-3.0 mm, about 3.0-4.0 mm, about 4.0-5.0 mm, about 5.0-6.0 mm,about 6.0-7.0, about 6.45 mm, or about 7.0-8.0.

In various embodiments, the first portion 207 includes a first diameter913 between planes 912A, 912B defined by outer surfaces of threads 107A,107B. According to one embodiment, the first diameter 913 measures about6.0-12.0 mm, about 6.0-7.0 mm, about 7.0-8.0 mm, about 8.0-9.0 mm, about8.0 mm, about 9.0-10.0 mm, about 10.0-11.0, or about 11.0-12.0. In oneor more embodiments, the first diameter 913 is based on a desired boresize for inserting the compression device 101 into a target site. In atleast one embodiment, the first diameter 913 is substantially similar tothe diameter 413 of the tip 109. In at least one embodiment, the threads107A, 107B the first diameter 913 tapers between the first end 701 andthe central region 902.

In one or more embodiments, the first portion 207 includes a seconddiameter 915 between planes 914A, 914B defined by inner surfaces of thethreads 107A, 107B. According to one embodiment, the second diameter 915measures about 2.0-8.0 mm, about 2.0-3.0 mm, about 3.0-4.0 mm, about4.0-5.0 mm, about 5.0-6.0 mm, about 6.0-7.0, about 6.5 mm, or about7.0-8.0. In one or more embodiments, the second diameter 915 provides aparticular resistance level to pullout forces experienced by thecompression device 101 at a target site. According to one embodiment,the first portion 207 and second portion 209 include a cannulationdiameter 917. In at least one embodiment, the cannulation diameter 917permits passage of connection bolt 211 and a guidewire through thesliding element 106. In one or more embodiments, the cannulationdiameter 917 measures about 1.0-4.0 mm, about 1.0-1.5 mm, about 1.5-2.0mm, about 2.0-2.5 mm, about 2.05 mm, about 2.5-3.0 mm, or about 3.5-4.0mm.

In at least one embodiment, the void 705 includes a length 919 betweenthe first end 701 and first section 909. According to one embodiment,the length 919 measures about 1.0-4.0 mm, about 1.0-1.5 mm, about1.5-2.0 mm, about 2.0-2.5 mm, about 2.5 mm, about 2.5-3.0 mm, or about3.5-4.0 mm.

FIG. 10 shows a cross-section 1000 of an exemplary insertion tool 102.In one or more embodiments, the insertion tool 102 includes a totallength 1001 between the second end 217 and the first end 215. In atleast one embodiment, the total length 1001 measures about 40-80 mm,about 40-50 mm, about 50-60 mm, about 53.75 mm, about 60-70 mm, or about70-80 mm. In various embodiments, the insertion tool 102 includes afirst portion 1003 between a region 1006 and the first end 215. In oneor more embodiments, the first portion 1003 includes a length 1005 thatmeasures about 20-60 mm, about 20-30 mm, about 30-40 mm, about 31.45 mm,about 40-50 mm, or about 50-60 mm. In various embodiments, the firstportion 1003 tapers from a first diameter 1007 (toward the region 1006)to a second diameter 1009 (toward the first end 215). According to oneembodiment, the first diameter 1007 measures about 9.0-15.0 mm, about9.0-10.0 mm, about 10.0-11.0 mm, about 11.0-12.0 mm, about 12.5 mm,about 12.0-13.0 mm, about 13.0-14.0, or about 14.0-15.0. In at least oneembodiment, the second diameter 1009 measures about 4.0-9.0 mm, about4.0-5.0 mm, about 5.0-6.0 mm, about 6.0-7.0 mm, about 6.5 mm, about7.0-8.0 mm, or about 8.0-9.0.

In one or more embodiments, the insertion tool 102 includes a secondportion 1010 between the second end 217 and the region 1006. In at leastone embodiment, the insertion tool 102 includes a cannulated region 1008running through both the second portion 1010 and first portion 1003. Inone or more embodiments, the cannulated region 1008 includes a diameter1011 that measures about 1.0-4.0 mm, about 1.0-1.5 mm, about 1.5-2.0 mm,about 2.0-2.5 mm, about 2.6 mm, about 2.5-3.0 mm, or about 3.5-4.0 mm.In various embodiments, the diameter 1011 is such that a portion of aconnection bolt 211 may be inserted through the cannulated region 1008.In various embodiments, the diameter 1011 is less than a diameter 1103of the connection bolt head 223 (FIG. 11), thereby preventing passage ofthe head 223 through the cannulated region 1008.

In at least one embodiment, the second portion 101 includes an opening1002 at the second end 217. In one or more embodiments, the opening 1002is configured for receiving a portion of a connection bolt 221 and forpreventing further insertion of the connection bolt 221 by interfacingwith the head 223 thereof (FIG. 2). In at least one embodiment, theopening 1002 includes a diameter 1013 that measures about 2.0-8.0 mm,about 2.0-3.0 mm, about 3.0-4.0 mm, about 4.0-5.0 mm, about 5.25 mm,about 5.0-6.0 mm, about 6.0-7.0, or about 7.0-8.0. According to oneembodiment, the diameter 1013 conforms to a diameter 1103 of the head223 (see FIG. 11). In one or more embodiments, the opening 1002 includesa length 1015 that measures about 2.0-6.0 mm, about 2.0-3.0 mm, about3.0-4.0 mm, about 4.0-5.0 mm, about 4.0 mm, or about 5.0-6.0 mm.According to one embodiment, the length 1015 conforms to a length 1105of the head 223.

In some embodiments, the insertion tool 102 includes indicia (not shown)and/or a gauge (not shown) for indicating a level of insertion of acompression device into a target site and/or a level of stretch in acompression element. In one example, the insertion tool 102 includes agauge that records a stretch length of the compression element based onmeasuring a tensile force applied to a sliding element to which thecompression element is connected. In another example, the insertion tool102 includes a plurality of indicia that are progressively revealed orhidden in response to progressive stretching of the compression element.

FIG. 11 shows a cross-section 1100 of a connection bolt 211. In one ormore embodiments, the connection bolt 211 includes a total length 1101between the first end 218 and the second end 220. In at least oneembodiment, the total length 1101 measures about 40-80 mm, about 40-50mm, about 50-60 mm, about 60.95 mm, about 60-70 mm, or about 70-80 mm.According to one embodiment, the head 223 includes a diameter 1103 thatmeasures about 2.0-6.0 mm, about 2.0-3.0 mm, about 3.0-4.0 mm, about4.0-5.0 mm, about 4.415 mm, or about 5.0-6.0 mm. According to oneembodiment, the diameter 1103 is based on a diameter 1011 of the opening1002 of the insertion tool 102 (see FIG. 10). In various embodiments,the head 223 includes a length 1105 between the first end 218 and an end1102 of the head 223. According to one embodiment, the length 1105measures about 1.0-4.0 mm, about 1.0-1.5 mm, about 1.5-2.0 mm, about2.0-2.5 mm, about 2.45 mm, about 2.5-3.0 mm, or about 3.5-4.0 mm. In atleast one embodiment, the length 1105 is such that the connection bolt211 is insertable through the insertion tool 102 and into thecompression device 101 to a predetermined length.

In one or more embodiments, the connection bolt 211 includes a shaft1106 between the end 1102 and the second end 220. In at least oneembodiment, the shaft 1106 includes a diameter 1107 that measures about1.0-4.0 mm, about 1.0-1.5 mm, about 1.5-2.0 mm, about 2.0-2.5 mm, about2.5 mm, about 2.5-3.0 mm, or about 3.5-4.0 mm. In one or moreembodiments, the connection bolt 211 includes a cannulated region 1108between the first end 218 and second end 220. In at least oneembodiment, the cannulated region 1108 includes a diameter 1109 thatmeasures about 0.5-3.0 mm, about 0.5-1.0 mm, about 1.0-1.5 mm, about 1.1mm, about 1.5-2.0 mm, about 2.0-2.5 mm, or about 2.5-3.0 mm. Accordingto one embodiment, the diameter 1109 is such that the connection bolt102 may be deployed along a guidewire passing through the cannulatedregion 1108. In various embodiments, the connection mechanism 221includes a length 1111 between an end 1112 and the second end 220. Inone or more embodiments, the length 1111 measures about 2.0-8.0 mm,about 2.0-3.0 mm, about 3.0-4.0 mm, about 4.0-5.0 mm, about 4.5 mm,about 5.0-6.0 mm, about 6.0-7.0, or about 7.0-8.0.

FIG. 12 shows a front view of an exemplary compression assembly 100. Invarious embodiments, the compression assembly 100 includes a length 1201between the second end 217 and the first end 104. According to oneembodiment, the length 1201 measures about 80-240 mm, about 80-120 mm,about 120-160 mm, about 154.75 mm, about 160-200 mm, or about 200-240mm. In one or more embodiments, the compression device 101 includes atotal length 1203 between the first end 701 and the first end 104. In atleast one embodiment, the total length 1203 measures about 80.0-120.0mm, about 80.0-90.0 mm, about 90.0-100.0 mm, about 100.0-110.0 mm, about100.5 mm, or about 110.0-120.0 mm. In one or more embodiments, thelength 1201 and/or the length 1203 are based on dimensions of a targetsite, such as, for example, a desired penetration distance of thecompression device 101 into the target site.

According to one embodiment, the compression device 101 shown in FIG. 12is in a pre-stretched state. As shown in FIG. 12, in at least oneembodiment, the sliding element 106 has been drawn fully upwards (e.g.,held in place via a connection bolt 211, not shown), thereby stretchinga compression element 201 (not shown) to a maximum stretch length. Inone or more embodiments, upon insertion of the compression device 101 toa target site, the connection bolt 211 may be disconnected from thesliding element 106, thereby transferring a compressive load to thesliding element 106. In one or more embodiments, the compressive loadapplied to the sliding element 106 by compression element 201 isaccompanied by an opposing compressive load applied to the threaded body103. In at least one embodiment, the opposing compressive loads aretransferred to surrounding tissue at the target site. In variousembodiments, the compressive loads are sustained as the compressionelement 201 contracts and attempts to return to an original pre-stretchlength.

FIG. 13 shows a bottom view of an exemplary compression device 101.

FIG. 14 shows a top view of an exemplary insertion tool 102 andconnection bolt 211.

FIG. 15 shows a back view of an exemplary compression assembly 100. Insome embodiments, a handle (not shown) is connected to the insertiontool 102 via one or more quick connect features 1501. In at least oneembodiment, the insertion tool 102 excludes the quick connect features1501 and, instead, receives a separate driver (not shown) that includesquick connect features for connection to the handle.

FIG. 16 shows a left-side view of an exemplary compression assembly 100.

FIG. 17 shows a right-side view of an exemplary compression assembly100.

Before turning to the process flow diagrams of FIG. 18, it is noted thatembodiments described herein may be practiced using an alternative orderof the steps illustrated in FIG. 18. That is, the process flowsillustrated in FIG. 18 are provided as examples only, and theembodiments may be practiced using process flows that differ from thoseillustrated. Additionally, it is noted that not all steps are requiredin every embodiment. In other words, one or more of the steps may beomitted or replaced, without departing from the spirit and scope of theembodiments. Further, steps may be performed in different orders, inparallel with one another, or omitted entirely, and/or certainadditional steps may be performed without departing from the scope ofthe embodiments.

FIG. 18 shows an exemplary compression process 1800, according to oneembodiment. At step 1803, the process 1800 includes assembling acompression device, such as a compression device 101 (FIG. 1). In atleast one embodiment, assembling the compression device includes, but isnot limited to, securing opposing ends of a compression element to asliding element and a threaded body, respectively. In one example, thecompression element, sliding element, and/or threaded body are rotatedto engaged threaded portions of each component and provide a secureconnection. In another example, bayonet or luer-lock style fittings areengaged between each element to assemble to compression device. In someembodiments, the compression element is threaded into the threaded bodyand sliding element substantially simultaneously.

At step 1806, the process 1800 includes connecting the compressiondevice to an insertion tool, such as an insertion tool 102 (FIG. 1). Invarious embodiments, connecting the compression device to the insertiontool includes, but is not limited to, inserting a plurality of pins(e.g., pins 108 shown in FIG. 1) through a plurality of voids in thesliding element such that the plurality of pins contact an end of thethreaded body (e.g., a second end 105 of the threaded body 103 shown inFIG. 1). In at least one embodiment, the plurality of voids allow thecompression device to translate along the plurality of pins (e.g., inresponse to a force applied at either end of the compression device).

At step 1809, the process 1800 includes stretching the compressionelement. In at least one embodiment, stretching the compression elementincludes securing a stationary position of the sliding element whileapplying a force to an end of the threaded body, thereby causing thethreaded body to translate away from the sliding element and resultingin the stretching of the compression element. In one example, thecompression device and attached insertion tool are placed into astretching device. In this example, a locking mechanism secures thestationary position of the sliding element by creating a threadedconnection between the locking mechanism and external threads of thesliding element. Continuing the example, after the sliding element issecured, a pushing mechanism applies a force to the insertion tool, andthe plurality of pins of the insertion tool translate the applied forceto the end of the threaded body. In the same example, the force causesthe insertion tool to translate toward the sliding element and causesthe threaded body to translate away from the sliding element, therebystretching the compression element. In some embodiments, the compressionelement is stretched until an end of the insertion tool contacts an endof the sliding element. In at least one embodiment, the compressionelement is stretched until a predetermined length of the plurality ofpins translates through the sliding element.

In some embodiments, stretching of the compression element occurs duringinsertion of the compression device to a target site. In one example,rotation of a compression device into a target site causes thecompression element to progressively stretch. In this example, thecompression device is rotated into the target site until a predeterminedlevel of stretch is achieved in the compression element.

At step 1812, the process 1800 includes securing the stretched positionof the compression element. According to one embodiment, the stretchedposition is secured while the compression device and insertion tool aredisposed within a stretching device. In at least one embodiment,securing the stretch of the compression element includes inserting aconnection bolt through the insertion tool and into the sliding element,and securely attaching the connection bolt to the sliding element (e.g.,in an impermanent manner such that the connection bolt may be detachedvia a tool). In one example, the connection bolt rotates into thesliding element such that corresponding threads on each component areengaged. In another example, rotating the inserted connection boltengages a bayonet or luer-lock style fitting. In at least oneembodiment, the connection bolt is inserted into the sliding elementsuch that an end of the connection bolt contacts an end of the insertiontool (e.g., or surfaces of an opening located at the same), therebypreventing further insertion of the connection bolt. In variousembodiments, upon release of the sliding element from the securedposition within the stretching device, the compression bolt preventsmovement of the insertion tool, thereby preventing contraction of thecompression element and preserving the stretched state of the same. Inother words, the inserted connection bolt opposes a tensile forceapplied by the compression element to the sliding element.

In some embodiments, steps 1803-1812 are performed as a first process ata first location (e.g., by a fabrication or assembly entity) and steps1815-1818 are performed as a second process at a second location (e.g.,by a surgeon or technician). In one example, a process for manufacturinga compression device includes steps 1803-1812 and a process for usingthe compression device includes steps 1815-1818.

At step 1815, the process 1800 includes inserting the compression deviceinto a target site including at least a first and a second bony fragmentto be compressed for the purposes of promoting healing. In one example,a surgeon rotates the compression device (e.g., via manual or motorizedrotation of the insertion tool) into a target site such that externalthreading of the sliding element lies in a first bony fragment andexternal threading of the threaded body lies in a second bony fragment.As will be understood from discussions herein, the sliding element maycontact a bony fragment (or other tissue) in any suitable way. In oneembodiment, the sliding element includes one or more external threads,such that the sliding element contacts a bony fragment via the one ormore external threads drilling into or otherwise engaging with the bonyfragment. In some embodiments, the sliding element may include a head(or other feature) such that a portion of the sliding element contacts asurface of a bony fragment (e.g., opposed to drilling into a bonyfragment).

At step 1818, the process 1800 includes engaging the compression elementsuch that a compressive force is generated between the first bonyfragment and the second bony fragment. In one example, a surgeondisconnects the connection bolt from the sliding element, therebycausing the sliding element to attempt to translate toward thecompression element (e.g., in response to the tensile force appliedthereby). In the same example, in response to tensile forces from thecompression element, the sliding element applies a first sustainedcompressive force to the first bony fragment and the threaded bodyapplies a second sustained compressive force to the second bony fragment(e.g., the first and second forces being applied in opposingdirections). Continuing the example, the compressive forces promoteossification and resettling between the first and second bony fragments.In this example, whereas previous compression solutions may losecompressive force overtime due to resettling and resorption of the bonyfragments, the compression element of the present compression devicedynamically responds to movement and structural changes at the targetsite to maintain substantially continuous and constant compression ofthe first and second bony fragments.

While various aspects have been described in the context of a preferredembodiment, additional aspects, features, and methodologies of theclaimed assemblies, devices, and processes will be readily discerniblefrom the description herein, by those of ordinary skill in the art. Manyembodiments and adaptations of the disclosure and claimed assemblies,devices, and processes other than those herein described, as well asmany variations, modifications, and equivalent arrangements andmethodologies, will be apparent from or reasonably suggested by thedisclosure and the foregoing description thereof, without departing fromthe substance or scope of the claims. Furthermore, any sequence(s)and/or temporal order of steps of various processes described andclaimed herein are those considered to be the best mode contemplated forcarrying out the claimed assemblies, devices, and processes. It shouldalso be understood that, although steps of various processes may beshown and described as being in a preferred sequence or temporal order,the steps of any such processes are not limited to being carried out inany particular sequence or order, absent a specific indication of suchto achieve a particular intended result. In most cases, the steps ofsuch processes may be carried out in a variety of different sequencesand orders, while still falling within the scope of the claimedassemblies, devices, and processes. In addition, some steps may becarried out simultaneously, contemporaneously, or in synchronizationwith other steps.

The embodiments were chosen and described in order to explain theprinciples of the claimed assemblies, devices, and processes and theirpractical application so as to enable others skilled in the art toutilize the assemblies, devices, and processes and various embodimentsand with various modifications as are suited to the particular usecontemplated. Alternative embodiments will become apparent to thoseskilled in the art to which the claimed assemblies, devices, andprocesses pertain without departing from their spirit and scope.Accordingly, the scope of the claimed assemblies, devices, and processesis defined by the appended claims rather than the foregoing descriptionand the exemplary embodiments described therein.

What is claimed is:
 1. A compression device assembly comprising: anelongate threaded body comprising: a threaded body first end comprisingone or more threaded body threads configured for affixing the threadedbody to a first bony fragment of a patient and defining a hollowinterior of the threaded body; and a threaded body second end comprisingan opening to the hollow interior of the threaded body; a slidingelement configured for contacting a second bony fragment of the patient,defining a hollow interior of the sliding element, and comprising: asliding element first end comprising an elongated portion shaped tointerface with the opening of the threaded body second end andcomprising one or more pin slots configured for receiving one or morepins of an insertion tool; a sliding element second end defining one ormore pin openings configured for receiving the one or more pins of theinsertion tool, wherein the insertion tool defines a hollow interior ofthe insertion tool and comprises one or more pins configured to bereceived by the one or more pin openings and the one or more pin slotsof the sliding element; and a cannulated compression element operativelyconnected to the threaded body and the sliding element, wherein: thecompression element is in a deformed state prior to insertion into thepatient; the compression element comprises nitinol; and the compressiondevice assembly is configured for: receiving a guidewire through thecannulated compression element; and applying compression to the firstbony fragment and the second bony fragment via the compression elementcomprises the compression element returning to a relaxed state from thedeformed state.
 2. The compression device assembly of claim 1, wherein alength of the one or more pin slots controls a maximum deformationdistance of the compression device assembly.
 3. The compression deviceassembly of claim 1, wherein the insertion tool is configured to receivea connection bolt through the insertion tool hollow interior.
 4. Thecompression device assembly of claim 3, wherein the sliding elementcomprises one or more connection bolt threads configured for connectingthe sliding element to the connection bolt.
 5. The compression deviceassembly of claim 4, wherein the connection bolt is configured to passthrough the insertion tool hollow interior and attach to the one or moreconnection bolt threads of the sliding element for holding the slidingelement in position with the compression element in the deformed state.6. The compression device assembly of claim 5, wherein the connectionbolt comprises: a first end configured for connection to the slidingelement; and a second end, opposite the first end, that is configured toprevent a full length of the connection bolt passing through theinsertion tool hollow interior.
 7. The compression device assembly ofclaim 5, wherein compression device assembly is configured for receivingthe guidewire through the hollow interior of threaded body, thecannulated compression element, and the hollow interior of the slidingelement, the hollow interior of the insertion tool, and through a hollowinterior of the connection bolt for guiding the compression deviceassembly to a particular location in the patient.
 8. The compressiondevice assembly of claim 7, wherein the compression assembly device isconfigured to, upon removing the connection bolt, apply compression tothe first bony fragment and the second bony fragment via the compressionelement returning to the relaxed state from the deformed state.
 9. Thecompression device assembly of claim 8, wherein the compression deviceassembly is configured such that the insertion tool is removable oncethe connection bolt is removed.
 10. The compression device assembly ofclaim 9, wherein the compression element is operatively connected to thethreaded body and the sliding element via threads.
 11. The compressiondevice assembly of claim 10, wherein a perimeter of the opening of thethreaded body second end comprises a hexagonal shape.
 12. Thecompression device assembly of claim 10, wherein: a set of threadsconnecting the sliding element and the compression element comprises afirst thread direction; and a second set of threads connecting thethreaded body and the compression element comprises a second threaddirection that is opposite the first thread direction.